Automatically reloading suture passer devices that prevent entanglement

ABSTRACT

Suture passers and methods of use. Described herein are suture passers preloaded with suture, including cartridges that couple to a suture passer to form a loaded suture passer that are configured to prevent a length of suture (e.g., already-passed suture) from re-entering the channel of the suture passer jaw and getting recaptured and/or entangled by the tissue penetrator. In particular, described herein are preloaded and automatically re-loading suture passers that are adapted to include a gate, guide, or shield on one of the jaws of the suture passer, and methods of operating such suture passers for surgical use including repairing tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/216,482, filed Jul. 21, 2016, titled “AUTOMATICALLY RELOADING SUTUREPASSER DEVICES THAT PREVENT ENTANGLEMENT,” which application claimspriority to U.S. Provisional Patent Application No. 62/195,141, filedJul. 21, 2015, titled “AUTOMATICALLY RELOADING SUTURE PASSER DEVICESTHAT PREVENT ENTANGLEMENT,” each of which is herein incorporated byreference in its entirety.

This patent application may be related to U.S. patent application Ser.No. 14/572,485, titled “AUTOMATICALLY RELOADING SUTURE PASSER DEVICESAND METHODS,” filed Dec. 16, 2014, now U.S. Pat. No. 9,492,162, whichclaims priority as a continuation-in-part to International PatentApplication No. PCT/US2014/030137, titled “SUTURE PASSER DEVICES ANDMETHODS,” filed Mar. 17, 2014, Publication No. WO 2014/145381, and U.S.Provisional Patent Application No. 61/916,735, titled “AUTOMATICALLYRELOADING SUTURE PASSER DEVICES AND METHODS,” filed Dec. 16, 2013. Eachof these applications is herein incorporated by reference in itsentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The methods and apparatuses (e.g., devices and systems) described hereinmay be used to suture tissue, particularly in difficult to accessregions. In particular, described herein are preloaded and automaticallyre-loading suture passers that are adapted to include a gate, guide, orshield on one of the jaws of the suture passer, and methods of operatingsuch suture passers for surgical use including repairing tissue.

BACKGROUND

Suturing of tissue during surgical procedures is time consuming and canbe particularly challenging in difficult to access body regions andregions that have limited clearance, such as regions partiallysurrounded or covered by bone. For many surgical procedures, it isnecessary to make a large opening in the human body to expose the arearequiring surgical repair. However, in many cases, accessing the tissuein this manner is undesirable, increasing recovery time, and exposingthe patient to greater risk of infection.

Suturing instruments (“suture passers” or “suturing devices”) have beendeveloped to assist in accessing and treating internal body regions, andto generally assist a physician in repairing tissue. Although many suchdevices are available for endoscopic and/or percutaneous use, thesedevices suffer from a variety of problems, including limited ability tonavigate and be operated within the tight confines of the body, risk ofinjury to adjacent structures, problems controlling the position and/orcondition of the tissue before, during, and after passing the suture,and difficulties loading the suture into the device, particularly forthreading multiple suture loops.

For example, some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

The knee joint is one example of a tissue region that is notoriouslydifficult to access. For example, the meniscus is a C-shaped piece offibrocartilage which is located at the peripheral aspect of the joint(e.g., the knee) between the condyles of the femur and the tibia on thelateral and medial sides of the knee. The central two-thirds of themeniscus has a limited blood supply while the peripheral one thirdtypically has an excellent blood supply. Acute traumatic events commonlycause meniscus tears in younger patients while degenerative tears aremore common in older patients as the menisci become increasingly brittlewith age. Typically, when the meniscus is damaged, a torn piece ofmeniscus may move in an abnormal fashion inside the joint, which maylead to pain and loss of function of the joint. Early arthritis can alsooccur due to these tears as abnormal mechanical movement of tornmeniscal tissue and the loss of the shock absorbing properties of themeniscus lead to destruction of the surrounding articular cartilage.Occasionally, it is possible to repair a torn meniscus. While this maybe done arthroscopically, surgical repair using a suture has provendifficult to perform because of the hard-to-reach nature of the regionand the difficulty in placing sutures in a way that compresses andsecures the torn surfaces.

The meniscus of the knee is just one example of a tissue that isdifficult to access so that appropriate suturing may be performed. FIG.2 illustrate the anatomy of the meniscus in the context of a knee joint.As shown in FIG. 2 the capsule region (the outer edge region of themeniscus) is vascularized. Blood enters the meniscus from themenisculocapsular region 291 lateral to the meniscus. A typical meniscushas a flattened bottom 298 (inferior surface or side adjacent to thetibia) and a concave top 296 (superior surface or side, adjacent to thefemur), and the outer cross-sectional shape may be somewhat triangular,with a meniscus tip region 294. The outer edge of the meniscustransitions into the capsule 291. The meniscus may includecircumferential fibers extending along the curved length of themeniscus, as well as radial fibers, and more randomly distributed meshnetwork fibers. Because of the relative orientations and structures ofthese fibers, and the predominance of circumferential fibers, it may bebeneficial to repair the meniscus by suturing radially (vertically)rather than longitudinally or horizontally, depending on the type ofrepair being performed. Most prior art devices for suturing or repairingthe meniscus are only capable of reliably repairingvertical/longitudinal tears. Such devices are not typically useful forrepairing radial or horizontal tears. Furthermore, prior art devicemechanisms have a high inherent risk for iatrogenic injury tosurrounding neurovascular structures and chondral surfaces.

Thus, there is a need for methods and apparatuses (e.g., devices andsystems) for suturing tissue, particularly tissue in difficult to accessregions of the body including the joints (shoulder, knee, etc.). Inparticularly, it has proven useful to provide a device that may simplyand reliably reach and pass sutures within otherwise inaccessible tissueregions. Such devices should be extremely low profile, and may beadapted or otherwise configured to fit in the tight spaces of thejoints. Finally, would be useful to provide suturing apparatuses thatallow selective and specific penetration of the tissue by both thetissue penetrator (needle element) and a jaw so that complex (includingright-angled) suturing patterns may be achieved.

Although a suture passers that may be preloaded or reloadable with oneor more sutures have been suggested, these devices typically requiremanual loading, activation and control of the suture in order tooperate. Suture passers that could pass two (or more) lengths of suture,including two or more portions of the same suture, without requiringmanual loading or reloading, would be highly advantageous, as they couldincrease the ease of suturing and reduce the time required for surgicalprocedures, as well as elimination or reducing a possible source ofoperational error.

To address these needs, U.S. application Ser. No. 14/572,485(incorporated by reference above) describes preloaded suture passersthat may pass multiple lengths (bights) of one or more suture.Unfortunately, when passing multiple lengths of suture using a preloadedsuture passer, one failure mode is the recapture or entangle thepreviously passed length of suture, when passing the second length ofsuture.

Described herein are preloaded suture passers, preloaded cartridges forsuture passers, and methods of operating such apparatuses to repairtissue capable of automatically passing a preloaded length of suture andautomatically preloading with a second length of suture, whilepreventing entanglement and/or entrapment of the first bight. Theseapparatuses (e.g., devices, including suture passers, and cartridges forsuture passers, and systems of suture passers) and the methods ofoperating them described herein may be used to access difficult-to reachtissues.

The apparatuses and methods described herein may address the needs andpotential benefits briefly discussed above.

SUMMARY OF THE DISCLOSURE

Described herein are preloaded cartridges for suture passers, preloadedsuture passers, systems including preloaded suture passers and/orcartridges for suture passers, and methods of operating any of these topass multiple lengths or suture and/or repair tissue, having a gate,shield, or otherwise configured to prevent a length of suture fromre-entering a channel in the preloaded cartridge (e.g., in the jawformed by the preloaded cartridge) and being entrapped by the tissuepenetrator within the preloaded cartridge. In particular, describedherein are preloaded cartridges in which a first length of suture ispreloaded into the tissue penetrator (e.g., needle) and, after passingthe first length of suture, the cartridge automatically applies tensionto load a second length of suture into the tissue penetrator; the jawformed by the preloaded cartridge includes a gate that prevents a lengthof suture outside of the cartridge from reentering the cartridge andbeing ensnared/entangled by the tissue penetrator.

Also described herein are suture passers that include a jaw memberadapted, e.g., by including a gate at the distal end to prevent a lengthof suture from re-entering the distal end of the suture passer andbecoming entrapped and/or captured and/or entangled by the tissuepenetrator, which may be loaded or configured to be loaded with a secondlength of suture. In general, the distal end of the jaw member (e.g., asecond or lower jaw member) typically includes a channel extendingproximally from the distal end region. The channel may be continuouswith a channel in which the tissue penetrator resides or slides so thatit can extend out of and retract into the jaw member to push a loop(bight) of suture through the tissue and engage another jaw (e.g., afirst or upper jaw) on an opposite side of the tissue. The gate isgenerally positioned at the distal end of this channel in the jawhousing the tissue penetrator. In some variations the gate is adeflectable gate (e.g. a deflectable pin, member, arm, etc.) thatextends across the channel opening. A deflectable gate is typicallyconfigured to open in a one direction (e.g., outwards relative to thechannel) and allow a length, loop or bight of suture to be pushed out ofthe channel, but be closed and resist opening in the opposite direction(e.g., inwards relative to the channel). Thus, the gate may be adeflectable gate that is configured to open in one direction only (e.g.,outwardly) but remain closed in the opposite direction. In somevariations, the gate may be configured to rotate or pivot to open andclose, and may be prevented from rotating/pivoting inwards. In somevariations the gate is bendable so that it can be deflected by changingshape (elastically) or bending on an elastic hinge region, to openoutwards and close to prevent a suture from entering the channel.

In some variations the distal end of the jaw is configured to preventreentry of a suture length by having a narrow and/or off-axis opening atthe distal end of the channel. For example, in some variations thedistal end of the jaw (e.g., the lower jaw housing the tissuepenetrator) is configured to have a rounded/curved distal surface with anarrow channel opening. In contrast, the distal end of the channelwithin the jaw may be shaped to encourage a length of suture to exit(but not reenter) the narrow opening at the distal end of the channel.

In some variations, the distal end of the jaw is configured so that theopening into the distal portion of the channel is offset on a side(e.g., a lateral side) of the jaw, making it much less likely that asuture would be recaptured into the channel an entangled by the tissuepenetrator.

Any of the suture passer devices described herein, including a gate toprevent entanglement of a length of suture as mentioned above, mayinclude a jaw that is part of or includes a cartridge. A cartridge maybe configured to be fully-enclosed, though with opening from which theloaded tissue penetrator may be extended and retracted. The cartridgemay be configured as a jaw for use with a suture passer, or may includea jaw region. The cartridge may be coupled to a durable (e.g., reusable)suture passer; the cartridge may be disposable or recyclable. Thecartridge may be coupleable to a suture passer, and may be slideable oradjustable once on the suture passer. The suture passer may engage withthe cartridge to control the position of the jaw portion of the suturepasser and/or the tissue penetrator.

In any of the apparatuses and methods described herein, the tissuepenetrator may be preloaded with a first bight of suture in a sutureengagement portion of the tissue penetrator, and may also include asecond bight of suture positioned to be loaded into the tissueengagement portion when the first bight has been passed by the suturepasser. The apparatus may include a releasable hold securing a portion(such as an end region) of the suture to the tissue penetrator so thatthis portion of the suture can move with the tissue penetrator; slidingthe tissue penetrator may therefore tension (e.g., pull taught) a regionof suture between the portion held by the releasable hold and a secondbight of suture. If the suture engagement portion of the tissuepenetrator (needle) is empty, the tension can pull the second bight ofsuture into the tissue engagement region for automatically reloading thesecond bight into onto the tissue penetrator. The second bight of sutureis typically held in a suture holding region that remains fixed relativeto the tissue penetrator.

A replaceable jaw cartridge that is preloaded with suture for use with asuture passer device may be configured to prevent entanglement and/orrecapture of a length of suture by the tissue penetrator. For example areplaceable jaw cartridge may include: a jaw housing configured toreleasably engage the suture passer device, the jaw housing having achannel extending proximally from a distal end region of the jawhousing; a tissue penetrator configured to slide distally and proximallywithin the jaw housing; a suture within the jaw housing, the suturecomprising a first bight region loaded in a suture engagement region ata distal end region of the tissue penetrator, and a second bight regionloaded in a suture holding region within the jaw housing; and a gate atthe distal end region of the jaw housing, wherein the gate is configuredto open distally to allow the release of the suture from the channel,and to close to prevent a portion of the suture from re-entering thechannel.

The gate may comprises a deflectable pin. In some variations, the gatecomprises a turnstile mechanism. The jaw housing may be configured tocompletely enclose the suture and tissue penetrator until the tissuepenetrator is extended from the jaw housing. The jaw housing maycomprise a keyed connector configured for coupling with an elongatemember of the suture passer device.

A suture passer apparatus (e.g., device or system) with a preloadedsuture may be configured to prevent entanglement and/or recapture of alength of suture that has already been passed by the apparatus and mayinclude: an elongate body extending distally and proximally; a first jawcoupled to a distal end of the elongate body; a second jaw having achannel extending proximally from a distal end region of the second jaw;a tissue penetrator configured to slide distally and proximally withinthe second jaw; a suture within the second jaw, the suture comprising afirst bight region loaded in a suture engagement region at a distal endregion of the tissue penetrator, and a second bight region loaded in asuture holding region within the second jaw; and a gate at the distalend region of the jaw housing, wherein the gate is configured to opendistally to allow the release of the suture from the channel, and toclose to prevent a portion of the suture from re-entering the channel.As mentioned, above the gate may comprise a deflectable pin (e.g., thatopens in one direction, to allow suture to exit, but not enter, thechannel), for example, the gate may comprise a turnstile mechanism.

The second jaw may be configured to enclose the tissue penetrator untilthe tissue penetrator is extended from the jaw housing.

As will be described in more detail below, in any of these apparatuses,the first jaw may be configured to pivot relative to the elongate bodyand wherein the second jaw may be configured to slide axially relativeto the elongate body.

Any of the apparatuses described herein (including preloaded cartridges,systems using preloaded cartridges, or integrated preloaded suturepassers) may also include in the enclosure or housing holding the tissuepenetrator and suture, one or more suture management elements such asguides, funnels, storage regions, spools, etc. to direct or hold thesuture.

Any of the apparatuses described herein may include a deflection surfaceat or near an exit through the jaw housing, wherein the deflectionsurface is configured to deflect the tissue penetrator away from the jawhousing as the tissue penetrator slides distally out of the exit. Thetissue penetrator may be generally configured to exit laterally from theside of the second jaw (e.g., the replaceable jaw cartridge). The tissuepenetrator may be an elongate, thin, flat, or otherwise bendablestructure. The tissue penetrator may be a metal (e.g., a shape memoryalloy such as Nitinol) that is capable of being stored in a relativelystraight configuration, and deflected one or more times when passing alength of suture, then restored to the relatively straight configurationwhen retracted back into the jaw housing.

A jaw housing may be configured to completely enclose the suture andtissue penetrator until the tissue penetrator is extended from the jawhousing. The jaw housing may be completely closed or it may include oneor more openings. The jaw housing may include a region configured as ajaw. This jaw region may be configured to mate with another jaw regionof a suture passer, such as an upper or pivoting jaw; the two jaws mayform a distal-facing opening that can be opened and closed relative toeach other to partially surround and/or grip target tissue to besutured. Thus, the jaw housing may include a tissue-engaging surfacethat can be positioned opposite another jaw surface on the suturepasser. The tissue-engaging surface may be smooth, or it may include atexture or geometry that aids in grasping and/or holding tissue.

In variations in which the cartridge is replaceably coupleable to asuture passer, the suture passer may not be competent to pass suturewithout a cartridge attached; for example durable portion of the suturepasser may include a handle, controls, an elongate body and a fixed orrotatable upper jaw member, but may lack a lower jaw (e.g., a slidinglower jaw) and/or a tissue penetrator. Such suture passers may bereferred to herein as durable (or reusable) suture passers, because theycan be re-sterilized and reused, or generally used with multiplereplaceable jaw cartridges.

Thus, in some variations the cartridge includes elements that helpconnect the cartridge to the durable suture passer. For example, a jawhousing may include a keyed connector configured for coupling with anelongate member of the suture passer device.

In general, the apparatuses described herein include a holding region(suture holding region) for holding the second bight of suture that willbe automatically re-loaded into the suture engagement region of thetissue penetrator. For example, any of these apparatuses may include asuture holding region that is configured as a notched region between thetissue penetrator and an inner surface of the jaw housing. The sutureholding region may act in conjunction with the releasable hold on thetissue penetrator to hold the length of suture between the sutureholding region and the reliable hold in tension. In some variations thesuture holding region pinches or grasps the second bight region of thesuture. In other variations the suture holding region does not apply anyforce to the second bight region; because the second bight region bendsover/within the suture holding region (e.g., a notch forming the sutureholding region) the second bight region may be held in the sutureholding region.

In general, the suture holding region may be configured to be positionedopposite from the suture engagement region of the tissue penetrator whenthe tissue penetrator is withdrawn proximally within the jaw housing.Thus, tension on the second bight region (e.g. from the releasable hold)may allow it to slide from the suture holding region into the sutureengagement region when the first bight is no longer in the sutureholding region and when the tissue penetrator has been positioned withinthe housing to align the suture engagement region with the sutureholding region.

Any appropriate suture may be used, including synthetic, natural orhybrid sutures. The suture may be monofilament or woven, and may becoated or uncoated. Although in some variations different suture may beused, in general the first and second bights of suture may be formedfrom different regions of the same suture. For example, the first bightregion may be formed as a bend in the suture located near a distal endof the suture and the second bight region may be formed as a bend in thesuture located near the proximal end of the suture.

In general, a releasable hold is attached to the tissue penetrator andmoves with the tissue penetrator; the releasable hold typically holds anend region of a suture against the tissue penetrator as it moves andholds the end region relatively fixed to the tissue penetrator,providing tension to the pull the second bight suture to load it intothe tissue penetrator. If the force (tension) on this length of sutureexceeds a threshold (e.g., a release threshold), the releasable holdwill release the suture; in some variations the suture is not completelyreleased above the threshold, but the releasable hold continues to applya holding force to the end region of the suture that is less than therelease force. In some variations the releasable hold stops applying aholding force when the tension exceeds the release threshold. Anyappropriate releasable hold may be used. In general, the releasable holdholds a portion of the suture against the tissue penetrator (needle).The releasable hold may push, press, clamp, pinch, bind, or otherwisetemporarily secure the suture against the suture passer. For example, areleasable hold may comprise one or more of: an O-ring, a clip, afriction releasable hold, a band, a clamp, a frangible hold, a wax hold,and a releasable adhesive. The releasable hold may include multipleholding sites (e.g., two or more mechanical holding sites, a mechanicalholding site and an adhesive holding site, etc.). In general, thereleasable hold is positioned proximally on the tissue penetratorrelative to the suture engagement region (which may be positioned nearthe distal tip of the tissue penetrator); the spacing from the distaltip/suture engagement region is typically greater than the distancetraveled by the tip of the tissue penetrator so that the releasable holdremains within the housing during normal operation. Although thereleasable hold is typically configured to attached to and move with thetissue penetrator, so as to hold an end portion of the suture fixed tothe tissue penetrator, in some variations the releasable hold may slideor be moved on/along the tissue penetrator. In other variations thereleasably hold may be fixedly attached to the tissue penetrator.

The needle may also be adapted to help releasable secure a portion ofthe suture with the suture engagement region. For example, the tissuepenetrator may be bent or shaped to help pinch the suture against thereleasable hold. In some variations the region of suture may also beconfigured to engage the releasable hold (e.g., including a knot, aglet,ferrule, etc.).

Any component that couples with (and slides with) the tissue penetratormay be configured as a releasable hold. For example a needle sled (sled)may be configured as a releasable hold. In general, the tissuepenetrator within the apparatus may be a sled distally/proximally andextended from and retracted back into the jaw housing (e.g., lower jawhousing, cartridge housing, etc.). Thus, the jaw housing may alsoinclude/enclose a sled (e.g., needle sled) configured to couple with thetissue penetrator to facilitate sliding of the tissue penetrator withinthe jaw cartridge. In variations in which the jaw cartridge isreplaceably coupled to a durable suture passer, either or both thetissue penetrator and/or the needle sled may couple with a shaft in thedurable suture passer that is also connected to a control on a handleregion to control the sliding (extension/retraction) of the suturepasser. The needle engagement region may be a keyed region that allowspushing and/or pulling of the tissue penetrator within and out of/intothe housing. The needle may be actuated independently of any sliding ofthe jaw housing relative to the durable suture passer, in variations inwhich the jaw housing (forming a second or lower jaw) may be slide/movedaxially and distally relative to the other jaw member of the suturepasser. In some variation the needle and the lower jaw may be moved inconjugate motion.

The sled may be configured as a releasable hold, so that the releasableis part of the sled. For example, the sled may from one or more narrowgap regions into which an end portion of suture may be pinched againstthe body of the tissue penetrator when the tissue penetrator is coupledwith the sled and loaded with suture. In some variations the distal endportion of the sled comprise one or more such gap regions for holding anend portion of the suture. In some variations the sled is configured tocouple with the tissue penetrator and releasable hold the end portion ofthe suture against the tissue penetrator. The tissue penetrator may bebent or curved (e.g., by the sled) to help hold the end region of thesuture against the tissue penetrator.

In variations of the apparatus in which the tissue penetrator couplesdirectly to an actuator to slide the tissue penetrator, the engagementbetween the tissue penetrator and the actuator (push/pull rod, shaft,etc.) may be configured as a releasable hold. Alternatively, a separatereleasable hold may be coupled to the tissue penetrator.

The housing (e.g., jaw housing) may also include a storage region forstoring the length within the housing. For example, the apparatus mayinclude a suture capsule region configured to hold a portion of thesuture. The storage capsule region may be at the proximal end of theapparatus. For example, in variations in which the first and secondbight are formed of the proximal and distal end regions of a singlesuture, the region of suture between the first and second bight mayextend proximally along the shaft of the jaw housing to a suture capsuleat the proximal end that has an enlarged hollow allowing storage of thisintermediate region of suture until it is drawn out of the distal end ofthe housing when passing the suture to the opposite jaw.

In variations in which the jaw housing is configured as part of acartridge, the apparatus may include a connector configured to couplethe jaw cartridge to the suture passer device and to uncouple the jawcartridge from the suture passer device. For example, the jaw housingmay include keyed regions, such as one or more projections (e.g.,flanges, pins, bumps, etc.), to engage with a recess region in thedurable suture passer device, or one or more receiving regions (e.g.,channels, slots, etc.) to receive projecting portions of the suturepasser device, or both.

In some variations, the jaw cartridge includes a suture guide within thejaw housing positioned intermediate of the distal end of the jaw housingand the releasable hold. For example, the housing may include or hold afunnel or channel in which the suture passes, which may help guide thesuture so that the movement of the tissue penetrator within the housingdoes not undesirably engage (e.g., tangle) the suture.

As mentioned, the jaw housing and/or the entire jaw cartridge mayslideably engage with a durable suture passer device so that jaw memberportion of the jaw housing slides distally to proximally along the longaxis of the suture passer, in contrast with and independently of anupper jaw on the durable suture passer, which in some variations pivotsrelative to the long (distal-to-proximal) axis. For example, the jawhousing may be configured to couple to and uncouple from a durablesuture passer to form a sliding lower jaw member on the suture passer sothat the tissue penetrator can extend from the jaw housing to an upperjaw member.

Also described herein are methods of operating any of the apparatusesdescribed. For example, described herein are methods of operating asuture passer that is preloaded with a suture. A method of operating asuture passer may include: forming a distal-facing opening between afirst jaw of the suture passer and a second jaw; extending a distal tipof a tissue penetrator across the distal-facing opening from within thesecond jaw, wherein the tissue penetrator comprises a suture engagementregion that is preloaded with a first bight region of the suture;retracting the distal tip of the tissue penetrator into the second jaw;withdrawing the tissue penetrator distally within the second jaw totension the suture between an end region of the suture that is held by areleasable hold on the tissue penetrator and a second bight region ofthe suture, so that the second bight region is drawn into the sutureengagement region of the tissue penetrator; and extending the distal tipof the tissue penetrator from the second jaw and across thedistal-facing opening, wherein the tissue penetrator is carrying thesecond bight region of the suture. The method may include the step ofpassing a length of suture out of a channel in the second jaw in a firstdirection, but preventing (e.g., via any of the gates described herein)a length of suture from entering the channel, thereby preventing alength of suture from getting entangled in the lower jaw.

The method may also include coupling a replaceable second jaw,configured as a jaw cartridge, to an elongate body of the suture passer,wherein the suture passer includes a first jaw pivotally coupled to adistal end region of the elongate body.

The step of forming a distal-facing opening between the first jaw of anda second jaw may comprise sliding the second jaw distally relative tothe elongate body to form the distal-facing opening between a distal endregion of the second jaw and the first jaw.

The method may also include uncoupling the jaw cartridge from the suturepasser.

In some of the methods of operating the apparatuses described herein,the method may also include pivoting the first jaw relative to theelongate body and sliding the second jaw distally to form thedistal-facing opening, and/or passing the first bight region of thesuture to the first jaw.

Also described herein are suture passers that have extremely lowprofiles. In some variations the devices are adapted so that the lowerjaw has a substantially lower profile by reducing the arc of the needleexit, by axially separating the lower jaw into a first (e.g., proximal)region controlling the axial translation (motion) of the lower jaw and asecond (e.g., distal) region that contains all of the features of thetissue penetrator pathway; these different regions may have differentheights, allowing nesting into the shaft particularly near the proximalend of the device.

Although this disclosure is divided up into parts, indication differentfeatures, any of these parts or individual features may be used alone orin combination with any other parts or features described herein orincorporated by reference.

In general, the first or second jaw may hold the tissue penetratorwithin an internal passage, and the tissue penetrator may be extendedbetween the distal-facing opening to push and/or pull a suture betweenthe first and second jaws. The tissue penetrator may be any appropriatematerial, but shape memory materials (e.g., shape memory alloys,plastics, etc.) are of particularly interest. The tissue penetrator mayhave a sharp (e.g., pointed, beveled, etc.) distal tip for penetratingtissue, which may be symmetric (e.g., having a central sharp point inthe mid-line of the long axis) or asymmetric (having a sharp point thatis not in the mid-line of the tissue penetrator). The tissue penetratormay be biased (e.g., pre-bent) in a curve or bend. In general the tissuepenetrator (e.g., needle) may extend from a side region of the first orsecond jaw, extend across the distal-facing opening, and connect to anopening on the side region of the opposite (e.g., second or first) jawfrom which it extends. This opening may include a suture capture regionthat holds the suture passed by the tissue penetrator. The suturecapture region may be a suture retainer that holds the suture whenpassed by the tissue penetrator. For example, the suture retainer may bea deflecting or deflectable clamping region, a hook, or the like.

In general, the tissue penetrator may be configured to bend as itextends from the jaw and across the distal-facing opening. For example,the tissue penetrator may be pre-biased to assume a bent or curvedconfiguration as it extends from within a jaw. Thus, the tissuepenetrator may extend approximately perpendicular to the side of the jawhousing it. In some variations the jaw includes a tissue penetratordeflection (e.g., ramped) region that helps deflect the jaw. In somevariations the jaw housing the tissue penetrator does not include adeflector.

For example, described herein are suture passers for forming a loop ofsuture around a target tissue, the suture passer comprising: an elongatebody extending distally and proximally along a long axis; a first jawextending from a distal end region of the elongate body wherein thefirst jaw is bent or bendable at an angle relative to the long axis; asecond jaw configured to slide axially along the long axis distally andproximally relative to the elongate body, further wherein the first jawand the second jaw form a distal-facing opening when the second jaw isextended distally and wherein the second jaw is retractable proximallyso that it does not form the distal-facing opening with the first jaw; atissue penetrator configured to extend across the distal-facing openingbetween the first jaw and the second jaw to pass a suture there between;and a plate having a keyhole capture region, wherein the keyhole captureregion comprise a capture pathway including a channel extending throughthe plate and a release pathway, wherein the capture pathway isconnected to the release pathway by at least one bend, further whereinthe plate is coupled to the first jaw so that it may receive a suturefrom the tissue penetrator extending from the second jaw. The capturepathway may comprise an opening mouth at an edge of the plate thattapers to a narrower channel before the release pathway. In somevariations, the release pathway comprises an enlarged opening having alarger diameter than the region of the capture pathway adjacent to therelease pathway. The bend may be configured to retain the sutureimmediately after it is passed into the keyhole capture region by thetissue penetrator.

Also described herein are apparatuses and method of operating them thatinclude are devices having a jaw that is adapted to fit into a tightregion of the body such as the knee joint, and particularly around themeniscus of the knee. The jaw member (e.g., upper jaw member) may beadapted to be bent (e.g., hinged) relative to a long axis of the (e.g.,elongate body of the) apparatus, and may include a proximal regionclosest to the end of the jaw hinged to the elongate body of theapparatus that is curved on an upper distally-extending surface and isrelatively flat on the lower distally-extending surface that contactsthe tissue. The flat lower surface may prevent the tissue from beingforced out from between the jaws as the upper jaw is closed towards alower jaw; the curved upper surface may allow the upper jaw member to bepositioned easily between the target tissue and a curved bone surfacesuch as the femur (e.g., the head region of the femur).

Tissue penetrators (e.g., needles) may also or alternatively be adaptedso that the distal tip region is sharp and tissue-penetrating, and isprotected (e.g., shielded or covered) relative to a central loadingregion that extends longitudinally through the jaw member (e.g., lowerjaw member) when the tissue penetrator is retracted into the deviceprior to being extended. Thus, the sharp distal tip of the needle may belocated slightly displaced relative to the middle of the width of thetissue penetrator at the distal end of the tissue penetrator (e.g.,offset by between about 1% and about 40% of the midline of the midlineof the width of the tissue penetrator, e.g., between about 1%, 2%, 3%,4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 15%, 20%, or 24% and about 25%, 30%,35%, 40% of the midline of the width of the tissue penetrator).

Any of the apparatuses described herein may include a tissue penetratorthat include a distal sharp tissue penetrator region that includes aside opening into a suture retaining region that is located justproximal to the distal tip; the proximal portion of the side opening maybe curved towards the proximal end of the tissue penetrator, so that thewidth of the side opening gradually increases to the overall width ofthe tissue penetrator as the outer edge of the side opening extendsproximally. This configuration may prevent tissue from snagging orcatching on this lower (proximal) edge region of the side opening whenextending the tissue penetrator distally through the tissue.

Also described herein are devices that include a suture guide feature,also referred to as a centering feature or centering channel, on the jaw(e.g., a first or lower jaw) in which the tissue penetrator andpreloaded suture are held; the centering feature may provide centeringforces on the preloaded second bight of suture so that it can bereliable pulled into the hook (suture engagement region) of the tissuepenetrator (needle). The suture guide feature may be referred to as acentering channel, as it may form a channel through a structure (such asthe jaw housing in which the tissue penetrator slides) that one leg ofthe second preloaded bight of suture is threaded through. The centeringfeature (centering channel) may include one or more openings, includingin some variations two openings, through which the suture leg isthreaded. When the centering channel includes two opening through thejaw housing or a structure attached to the jaw housing, a recessedconnecting channel may be formed between the two openings. The recessedconnecting channel portion of the centering channel may reduce frictiondue to contact between the suture and the tissue being held in the jaw.For example, described herein are replaceable jaw cartridges for usewith a suture passer device, the jaw cartridge comprising: a jawhousing; a tissue penetrator configured to slide distally and proximallywithin the jaw housing; a suture within the jaw housing, the suturecomprising a first bight region loaded in a suture engagement region ata distal end region of the tissue penetrator, and a second bight regionloaded in a suture holding region within the jaw housing; a centeringchannel through which the second bight region is threaded, wherein thecentering channel is positioned opposite from (e.g., radially inward of)and proximal to the suture holding region; and a releasable hold thatmoves with the tissue penetrator and releasably secures a first endregion of the suture against the tissue penetrator; wherein thereleasable hold is configured to hold a portion of the suture betweenthe first end region and the second bight region so that the portion isin tension when the tissue penetrator is withdrawn proximally so that acentering force is applied to the second bight region to pull the secondbight region from the suture holding region into the suture engagementregion of the tissue penetrator.

Although this example above (and shown herein) is described as areplaceable cartridge including a jaw, the apparatus may be part of asuture passer that is not configured as a removable cartridge. Further,although the centering element (centering channel) show in the examplesprovided herein is formed through an upper surface of the jaw housing inwhich the needle slides, it may be formed of a separate structure thatis coupled to the jaw housing, rather than part of the housing itself.For example, the centering channel may be a loop attached to the jawhousing (so that it does not move relative to the jaw housing, even whenthe tissue penetrator moves, or when the jaw as a whole moves relativeto the device), such as a wire loop; the loop (channel) may be withinthe jaw housing.

As mentioned above, any of the apparatuses described herein may includesome or all of the features described and illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows one variation of a suture passer having a bent/bendableupper jaw and a lower jaw that slides axially (distal-to-proximal) inthe long axis, with the lower jaw retracted.

FIG. 1B shows a close-up of the distal end FIG. 1A with the lower jawextended. The suture passer in FIGS. 1A and 1B may include an integratedpreloaded and automatically reloading suture.

FIGS. 1C and 1D show side perspective views of an example of a suturepasser apparatus formed of a reusable/durable suture passer assemblyincluding the upper (pivoting) jaw, elongate body and handle withcontrols, to which a preloaded and automatically reloading cartridgeforming the lower jaw assembly has been attached. In FIG. 1C thecartridge is coupled to the suture passer assembly and the lower jaw isfully retracted (thus the cartridge is fully retracted). In FIG. 1D thesame suture passer apparatus is shown with the lower jaw extended toform a distal-facing opening between the upper jaw and the lower jawregion of the cartridge.

FIG. 2 illustrates the anatomy of the meniscus, including the capsuleand associated vascular tissue.

FIG. 3A shows an example of a suture passer assembly (which may beconfigured as a reusable/durable suture passer assembly) such as the oneshown in FIGS. 1C and 1D without a cartridge attached.

FIG. 3B shows a cartridge (including a lower jaw housing, tissuepenetrator, and suture) that is configured to be preloaded andautomatically reloading the suture.

FIG. 3C shows the suture passer assembly of FIG. 3A being coupled to thecartridge of FIG. 3B.

FIG. 4A shows an enlarged isometric view of one example of a preloadedand automatically reloading cartridge.

FIG. 4B shows an exploded view of the cartridge of FIG. 4A.

FIGS. 5A-5C show top, side perspective and side views, respectively, ofthe distal end of a preloaded and automatically reloadable cartridgesuch as the one shown in FIG. 4A.

FIG. 6 is an exploded view of a distal end region of one variation of apreloaded and automatically reloadable cartridge.

FIG. 7A shows an enlarged view of the distal end region of a preloadedand automatically reloadable cartridge such as the one shown in FIGS.5A-5C.

FIG. 7B shows an enlarged view of the cartridge housing for thepreloaded and automatically reloadable cartridge of FIG. 7A.

FIG. 7C is a partial perspective view, with some of the componentsremoved or made partially transparent, showing the relationship betweenthe tissue penetrator, suture and releasable hold, lower jaw housing,and top of one variation of a preloaded and automatically reloadablecartridge such as the one shown in FIGS. 7A-7B.

FIGS. 8A-8L illustrate one method (including optional steps) ofoperating a system such as the systems described herein including apreloaded and automatically reloadable cartridge to repair tissue. InFIGS. 8A-8L, the tissue being repaired corresponds to knee meniscustissue.

FIGS. 9A and 9B illustrate a failure mode of a suture passer in which aportion of a first region of suture (e.g., first bight or loop) isundesirably recaptured by the device when a second region (e.g., secondbight or loop) is passed. FIG. 9A illustrates passing of the first bightthrough the tissue, and FIG. 9B shows the resulting entangled or trappedconfiguration after passing the second bight through the tissue.

FIG. 9C is a picture illustrating a clinical example of thisentanglement/entrapment of a portion of the first bight when passing thesecond bight using a preloaded suture such as those illustrated above.

FIG. 10 illustrates a first embodiment of a preloaded suture passerhaving a gate (e.g., barrier, shown in this example as a turnstile-typegate or barrier) to prevent a region of suture, e.g., from the firstbight, from inadvertently falling back into the channel or opening inthe lower jaw member housing the suture passer/needle, therebypreventing entanglement of the suture with the second bight/loop beingpassed by the preloaded suture passer device.

FIGS. 11A-11H illustrate the operation of the gate shown in FIG. 10 toprevent a first region of suture from reentering the jaw member whenpassing a second region of suture.

FIG. 12A illustrates another configuration of a preloaded suture passer(e.g., preloaded lower jaw member of the suture passer) configured toprevent entanglement/entrapment of another (e.g., first bight) region ofa suture when passing a second region (e.g., second bight). In thisexample, the preloaded jaw is configured so that the first region ofsuture (the region between the first bight/loop preloaded and the secondbight/loop preloaded is wound around the outside (or within a channelin/on) the lower jaw member.

FIG. 12B illustrates the back of the preloaded jaw member shown in FIG.12A.

FIG. 13A illustrates a symmetric tissue penetrator (needle).

FIGS. 13B and 13C illustrate examples of asymmetric tissue penetrators(needles).

FIG. 14A shows a top view of a lower jaw member having a tissuepenetrator such as the one shown in FIG. 13B, with a laterallypositioned sharp tip (relative to the width of the tissue penetrator).

FIG. 14B shows an example of a lower jaw including a tissue penetratorsuch as the one shown in FIG. 14A, in which the distal tip region isless than 40% off-center. The lower jaw member includes a tip shieldregion in the central suture loading channel to prevent a suture fromsnagging on the sharp distal tip when loading/unloading into the tissuepenetrator. This may also prevent entanglement/entrapment of a region ofsuture as described herein.

FIG. 15 illustrates another variation of a lower jaw member of apreloaded suture passer configured to prevent entanglement and/orentrapment of a region of suture when passing a second (or a secondregion of a) suture. In this example, the lower jaw member has anopening only at the lateral side, not the distal end, out of which thesuture loop may pass.

FIG. 16 is another example of a variation of a lower jaw member of apreloaded suture passer configured to prevent entanglement and/orentrapment of a region of suture when passing a second (or a secondregion of a) suture. In this example, the opening at the distal end isnarrow, and shaped with the outer-facing (distal-facing) surfacerounded, to prevent or reduce the likelihood that a region of suturefrom entering into the opening before or during passing of a secondlength of suture.

FIGS. 17A-17E illustrate one example of passing a first preloadedsuture, automatically reloading a second end of the suture that is alsopreloaded and passing the second end.

FIGS. 18A and 18B illustrate a first example of a suture passer lowerjaw portion including a centering channel (e.g., a suture guide) thatmay be help direct the second bight of suture into the needle (tissuepenetrator) hook region.

FIG. 19A-19D illustrate variations of jaw members including centeringchannels configured to applying a centering force vector to guide thesecond bight from the lateral suture engagement region into tissuepenetrator hook region.

FIGS. 20A and 20B illustrate problems that may occur when loading thesecond bight that is otherwise preloaded into the suture engagementregion into the hook region of a tissue penetrator.

DETAILED DESCRIPTION

In general, described herein are sutures passers configured to prevent alength of suture from re-entering a channel in the preloaded cartridge(e.g., in the jaw formed by the preloaded cartridge) and being entrappedby the tissue penetrator within the preloaded cartridge, methods ofoperating them, and methods of repairing tissue using them. These suturepassers may be used arthroscopically, and may be used to pass one ormore length of suture. These suture passers may include an elongate bodyand a first jaw member (e.g., first jaw) extending from the distal endof the elongate body, wherein the first jaw is bent or bendable relativeto the distal to proximal axis of the elongate body. In some variationsthe first jaw is hinged near the distal end region of the elongate body.Some variations of the suture passers described herein include a secondjaw member (e.g., second jaw) that is configured to slide axially(proximally and distally) relative to the elongate body and/or firstjaw. The second jaw may be configured to slide axially sufficiently farproximally so that the distal tip of the second jaw is proximal to thedistal end of the shaft (e.g., completely retracted). The first andsecond jaws may be configured to form a distal-facing opening into whichtissue may be held. The suture passers described herein may also includea flexible, bendable, or pre-bent tissue penetrator for passing a suturethrough the tissue. The suture passer may also include a handle at theproximal end with one or more controls for actuating the first and/orsecond jaws and the tissue penetrator.

The suture passer described herein may have very narrow (thin) jaws. Thetissue penetrator may exit the second jaw from the side of the secondjaw and extend across a distal-facing opening to engage an opening inthe opposite jaw (e.g., the first jaw), where a suture may be securedand/or released. For example, the suture passers described herein mayhave a second jaw having a maximum diameter (e.g., maximum height) alongthe length of the second jaw of less than about 0.11 inches, 0.10inches, 0.09 inches, 0.08 inches, 0.07 inches, 0.06 inches, 0.05 inches,0.04 inches, 0.03 inches, 0.2 inches, 0.01 inches, etc. The second jawmay be any appropriate width. For example, the width may beapproximately 0.15 inches.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Preloaded Suture Passers

In general, any of the suture passer described herein may be adapted orconfigured prevent a length of suture from re-entering a channel in thepreloaded cartridge (e.g., in the jaw formed by the preloaded cartridge)and being entrapped by the tissue penetrator within the preloadedcartridge. FIGS. 1A-1D, and 3A-7C illustrate apparatuses, includingsuture passers and cartridges for suture passers, that may be configuredas described herein to prevent suture from being drawn back into thedevice where it could be entrapped and/or entangled with the tissuepenetrator. For example, any of the suture passers described herein inFIGS. 1A-1D and 3A-7C may be configured as shown in any (or one or moreof) FIGS. 10-11H, 12A-12B, or 15. For example, any of the suture passersand cartridges for suture passers that are preloaded with one, or morepreferably, more than one, length of suture that can be passed throughtissue by the suture passer without requiring manual loading may includea gate (e.g., a deflectable gate) that prevents a length of suture fromre-entering a distal channel in a lower jaw of the suture passer orpreloaded suture passer cartridge and becoming entrapped by the tissuepenetrator. A preloaded suture passers and cartridges for suture passersmay include a suture holding/tensioning mechanism, which may be referredto as a releasable hold that is connected to, and may ride on, thetissue penetrator (“needle”); the releasable hold releasably secures anend of the suture and provides sufficient tension to load the sutureonto the tissue penetrator during operation. A tissue penetrator mayalso and alternatively be referred to as a needle. A tissuepenetrator/needle is generally configured to pierce tissue and pass(push and/or pull) suture. A tissue penetrator may be flat, cylindrical,etc. and may have a square, oval, circular, or other shapedcross-section. The tissue penetrator is generally elongated and mayinclude a notch, eye, hook, or the like for engaging a suture near or atits distal end.

In general, a suture passer device as described herein may be referredto as suture passer and/or a suturing device. Any of the featuresdescribed herein may be included as part of a low-profile suture passerthat includes a pair of jaws (e.g., distal-facing jaws) between whichthe needle may extend to pass suture. The low-profile suture passers maybe configured to allow axial (sliding) movement of a jaw of the suturepasser relative to the elongate body of the suture passer; the suturepasser may also be configured so that the opposite jaw of the suturepasser pivots or rotates relative to the elongate body of the suturepasser, so that tissue can be clamped between the jaws before and/orduring suturing. Low-profile suture passers having both sliding androtating jaws may be referred to as dual deployment suture passers,and/or clamping/sliding suture passers.

For example, a suture passer may generally include a first jaw memberand second jaw member that both extend from the end of an elongate bodyregion to form a distal-facing mouth into which tissue to be suturedfits. One or both jaws forming the mouth may be independently moved.FIGS. 1A and 1B illustrate one variation of a dual deployment suturepasser 100. In this example, the device has a first (upper) jaw member103 extending distally from the distal end of a more proximal elongatemember 101. A second jaw member 105 (in FIG. 1B) extends distallybeneath the first jaw member 103. This second jaw member may slidedistally and proximally to retract and extend. A handle 107 is locatedat the proximal end of the device and includes multiple controls forindependently controlling the movements of the first jaw 103, second jaw105, and tissue penetrator (not shown in FIGS. 1A and 1B, though it maybe housed with the tip retracted within either the first or second jaws.

One example of a suture passer that may be configured as a preloadedsuture passer is shown in FIGS. 1A and 1B. In FIG. 1A, a first jawmember 103 is held at an angle relative to a long axis of the proximalelongate member 101. The first jaw 103 in this example is curved(“radiused”) slightly and connected to the elongate body by a hingeregion 113 about which the first jaw 103 may be angled relative to theelongate member 101. In some variations, this hinge region is a pinnedhinge; non-pinned (e.g., living hinges) regions may be used. Anyappropriate articulating region that allows the first jaw member to moveat an angle relative to the proximal portion of the device (e.g., theelongate member) may be used. In some variations, this first jaw member103 is referred to as an upper jaw member, but alternative variations(in which the first jaw member is a lower jaw member) are also possible.

A jaw lever 181 can be used to move (bend) or hold the first jaw member103 angle. The first jaw member 103 may be actuated by any appropriatemechanism, including a tendon member (e.g., push rod, pull rod, or thelike), and may be held (locked) at any angle (e.g., between 0° and 180°relative to a line extending from the distal end of the elongate body,between about 0° and 90°, between about 0° and 60°, etc.). In somevariations the device has a neutral position during which no force isapplied to the controller to move the first jaw member, so that thefirst jaw member is angled “open” (e.g., at 30°, 45°, 50°, 90° or at anyangle between about 15° and about 90°) relative to the elongate body;actuating (e.g., pressing) the control on the handle results in thefirst jaw member moving towards the “closed” position (e.g., reducingthe angle with respect to a line extending from the distal end of theelongate body). In some variations the jaw member is in the neutralposition when angled with 0°/180° relative to the elongate body.

The first jaw member 103 shown in FIGS. 1A and 1B also includes a sutureretainer region near the distal end. A suture retainer can hold a suturethat has been passed into the suture retainer from the tissuepenetrator. This suture retainer region may include a grasper, a pair ofgraspers, a deflectable member into which the suture may be pushed andheld (e.g., handed off from the tissue penetrator), or the like. Forexample, the retainer may be a leaf spring element that is displaced bythe tissue penetrator as it enters the jaw member in variation in whichthe tissue penetrator is housed in/behind the lower (sliding) jaw.

The second jaw 105 is shown in FIG. 1B as a lower jaw member. In thisvariation, the lower jaw 105 is configured to slide proximally towardsand into the proximal elongate body 101 of the device (as shown in FIG.1A). The second jaw 105 typically moves axially, in the direction of theproximal-distal axis of the suture passer. The second jaw member 105 maymove axially completely past the distal end of the elongate body;alternatively, the second jaw member 105 may slide axially in theproximal direction only partially (e.g. to align with the hinge regionof the first jaw member). The suture passer may be configured so thatthe second jaw 105 can retract completely into, and extend out of, thelower portion of the elongate body 101. A control (e.g., retractorlever) 171 on the handle 107 can be used to trigger retraction of thesecond jaw member 105 while another control (e.g., lower jaw/needlelever) 191 can be used to extend the second jaw 105. In FIGS. 1A and 1B,the lower jaw/needle lever is configured to both extend the lower jawwhen squeezed once, and to extend and retract the tissue penetrator(needle) when squeezing the lever a second time; squeezing the secondtime extends the needle and releasing the lever retracts the needle.

A tissue penetrator (not visible in FIGS. 1A and 1B) may be housedwithin or behind the second jaw 105. Alternatively, the suture passermay be configured so that the tissue penetrator is housed within orbehind the upper jaw and the suture retainer region is on the opposite(e.g., lower) jaw. The tissue penetrator may be configured as a needle,wire, knife, blade, or other element that is configured to extend fromwithin either the first or second jaw members and across the openingbetween the jaw members to engage a suture and push the suture throughthe tissue from a first jaw (e.g., the lower jaw) where it can be heldby the suture retainer region on the opposite jaw (e.g., the upper jaw).In general, the tissue penetrator may be configured to completelyretract into the housing of the second jaw member 105. It may beextended across the opening between the jaws by actuating a member inthe handle to push or otherwise drive (slide) it out of the jaw anddeflect it across the opening, and though any tissue held between thejaws. In FIGS. 1A and 1B, the second jaw member 105 completely housesthe tissue penetrator and includes a deflection region that drives thetissue penetrator up and out of the second jaw member by deflecting itacross the opening between the two. The jaw/needle lever 191 can be usedto extend the tissue penetrator (for example, a first squeeze canadvance the second jaw member 105 and once the lower jaw is extended, anadditional squeeze or squeezes can extend the needle.

A suture passer, such as the suture passer described in FIGS. 1A and 1B,can be configured to be preloaded with suture for multiple passes. Thiscan be performed either with a replaceable cartridge or by configuringthe lower jaw of the suture passer to include a suture having a firstbight (e.g., bend, loop, etc.) region, a second bight region, a tissuepenetrator holding the first length (bight) of suture, a suture holdingregion holding the second bight, and a releasable hold on the suturepasser that drives the second bight region from the holding region tore-load the tissue penetrator after the first bight has been passed.

For example, a suture passer apparatus as described herein may beconfigured to operate with cartridge (e.g., a preloaded cartridge). Ingeneral, the preloaded cartridge may be part of a replaceable assemblythat is preloaded with suture; the preloaded cartridge engages with adurable assembly including components of the suture passer that can bereused, while the cartridge includes “disposable” components (e.g.,suture, tissue penetrator) that are consumable, and/or limited-use.

In general, a cartridge may include one of the jaw members of a suturepasser, such as the lower jaw, the suture, and the tissue penetrator, aswell as a releasable hold that re-loads the suture into the tissuepenetrator after it has been passed. A cartridge may also include ahousing that completely or partially covers the suture and tissuepenetrator. The housing may also include a storage region (e.g.,capsule) for holding the length(s) of suture, and any additional suturemanagement components (e.g., funnels, channels, spools, etc.) forguiding the suture. As mentioned above, in some variations a removable,replaceable and/or releasable cartridge is not used, but the entiresuture passer may be preloaded with suture and disposable after use.

In some variations of the cartridge described herein the cartridge ispreloaded with suture and a tissue penetrator and engages with a durablesuture passer body. The reusable or durable suture passer body may bereferred to as a durable portion or durable assembly of a suture passerapparatus. In general, the durable portion may include an elongate body,a first jaw member (e.g., pivoting, bent, bendable, or fixed), and ahandle including controls for controlling movement of the jaw(s) andtissue penetrator. The replaceable cartridge portion may be referred toas a cartridge assembly, and typically includes a housing attached to orforming all or part of a (e.g., second) jaw, a tissue penetrator (e.g.,needle) and a suture. The suture is typically both preloaded into thetissue penetrator and may also be “primed” for loading a second lengthinto the tissue penetrator after the first length has been passed fromthe tissue penetrator.

For example, the second jaw member 105 can be part of a suture cartridgethat is configured to hold at least two preloaded loops of suture to bepassed. Further, as described more detail below, the suture cartridgecan be configured to attach to and detach from the rest of the apparatus(e.g., to the durable assembly portion of the suture passer).

FIGS. 1C and 1D illustrate a suture passer 200 that is configured as aclamping/sliding suture passer, having both a sliding lower jaw 205 andbending/pivoting upper jaw 207, where the lower jaw is formed as part ofa preloaded cartridge 203. In FIG. 1C the durable assembly 201 and thereplaceable cartridge assembly 203 are combined to form the suturepasser 200. When combined, the operation of the device may be controlledas described above. The handle 209 includes a first control (upper jawor bending jaw control) 211 for controlling the angle of the upper jaw202, a second control (e.g., jaw extending/needle extending control) 213for controlling extension of the lower jaw and extension/retraction ofthe tissue penetrator, and a lower jaw release 215 control that retractsthe lower jaw after it has been extended. In FIGS. 1C and 1D, the lowerjaw is part of the cartridge assembly and in FIG. 1C is shown retractedproximally relative to the elongate shaft 220 of the apparatus. In FIG.1D, the lower jaw 205 is shown extended distally relative to the longaxis (e.g., the distal-to-proximal axis of the elongate body 220); thismay be achieved by actuating (e.g., squeezing) the second control toextend the entire cartridge 203 and therefore the lower jaw region 205distally. When extended distally the upper 202 and lower 205 jaws form adistal-facing opening across which a tissue penetrator (not shown) maybe extended from the cartridge to pass the preloaded suture.

FIG. 3A illustrates one embodiment of a durable assembly 300 of a suturepasser, without the attached cartridge shown in FIG. 3B. In FIG. 3A, thedurable assembly includes the upper jaw 302, an elongate body 320, and ahandle 330 with controls. The durable assembly is adapted for releasablycoupling with a preloaded cartridge, such as the one shown in FIG. 3B.For example the durable assembly may include one or more keyed regionsto which a cartridge may be coupled. The cartridge may therefore includecomplementary regions for engaging the durable assembly. An example ofhow a cartridge may be engaged with a durable assembly to form thesuture passer is described in greater detail below.

FIGS. 3B and 3C show perspective views of a cartridge 301 that includesa jaw (lower jaw) region 305 and a housing 309 that at least partiallyencloses a suture, tissue penetrator, suture holding region andreleasable hold on the tissue penetrator. In this example, the housingincludes a lower jaw region 305, an elongate region 319, and a suturecapsule 321. The suture capsule stores at least a portion of the sutureto be passed. In some variations a single long (e.g., 2 inches, 3inches, 4 inches, 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10inches, 12 inches, 13 inches, 14 inches, etc.) length of suture may beused to form both a first bight region and a second bight region thatare separately passed by the device and loaded automatically and/orpreloaded into the tissue penetrator by the cartridge. The first bightmay be at one end region and the second bight may be at the other endregion. As indicated in FIG. 3C, the cartridge 301 may be connected anddisconnected from the durable assembly 300. Thus, in operation a newpreloaded cartridge 301 may be connected to a durable assembly 300, thedevice may be used (e.g., to pass two lengths/bights of suture) and theassembly may be removed and a fresh (preloaded) cartridge attached. Theused cartridge may be refurbished (e.g., by replacing the suture and/orthe tissue penetrator), reloaded, recycled, or otherwise disposed of. Aportion of the cartridge may be inserted into the durable assembly. Forexample, in FIG. 3C, the suture capsule region 321 may be retracted intoa portion 325 of the handle when the lower jaw is retracted proximally.

The elongate body 101 shown in FIGS. 1A-3C is illustrated as arelatively straight, flattened and cylindrical structure, though othershapes may be used. For example, the elongate body may be curved, bent,or angled. In some variations the elongate body is configured to bebent, curved or angled dynamically (e.g., by changing the bend orcurve).

The elongate body of the suture passer (which may include both theelongate body region of the durable component and/or the elongate bodyportion of the cartridge that can mate with the durable component) maybe any appropriate length. For example, the elongate body may be betweenabout 6 and about 24 inches long, e.g., 6 inches long, 8 inches long, 10inches long, 12 inches long, etc. The suture passers described hereinmay be used for arthroscopic surgeries and therefore may be dimensionedfor use as such. Thus the diameter of the device may be configured to besmall enough for insertion into a cannula, tube or the like forinsertion into the body.

In general, a suture can be preloaded in a suture cartridge 1000 for usein automatically and sequentially passing two or more lengths of suturewith a suture passer, such as the suture passers of FIGS. 1A-1B or1C-1D. FIG. 4A illustrate a variation of a suture cartridge 400configured to be used as part of a suture passer that can hold and passtwo lengths of suture. As mentioned, the suture cartridge 400 can beconfigured to attach and detach from a durable assembly of a suturepasser. The suture cartridge 400 in this example includes a lower jaw405 (i.e., similar to the lower jaw 105 of FIGS. 1A and 1B) as well as asuture storage capsule 421.

The lower jaw 405 can include a housing 409 that encloses a tissuepenetrator 403 and first and second bights. A track can run within thehousing 409 of the cartridge along which the tissue penetrator 403 canslide when moving within and/or extending in and out of the cartridge.The track can be sized such that the tissue penetrator 403 fits withinthe track but prevents the suture from engaging in the track. A sutureholding region (not visible in FIG. 4A) may be formed between thehousing (e.g., the track) and the tissue penetrator, for holding thesecond bight region of suture. A top cover 407 can be placed over adistal portion of the housing which may help retain the ends of thesuture(s), including the bight regions, in a correct position within thecartridge.

FIG. 4B shows an exploded view of the cartridge shown in FIG. 4A. Thecartridge may be assembled to include the housing 409, which may bereferred to as a jaw housing or lower jaw housing. A suture holdingregion (suture capsule 421) may be integral with the jaw housing orseparate from it, but is attached so that the suture can continue fromthe jaw housing to the suture holding region. If the holding region 421is separate from the jaw housing 409, a connection tab 419 may beattached over the housing at the proximal end of the cartridge and maysecure the holding region to the rest of the housing. The inner region410 of the housing may be configured to hold the suture and tissuepenetrator, and also to allow the tissue penetrator to slide within andout of the housing. For example, the inner region 410 of the housing mayinclude a distal deflector (ramp) region 433. The housing 409 may alsoinclude the engagement regions such as extending structures (posts,flanges, etc.) that may be keyed to complementary engagement regions ona durable assembly to secure the durable assembly and the cartridgetogether. In FIG. 4B, two sets of flanges or keyed regions 444, 446 areshown.

A suture 460 and tissue penetrator 403 may also fit within thecartridges lower jaw housing. In FIG. 4B, the suture is shown coupled tothe tissue penetrator so that a first bight is preloaded into a notchregion forming a suture engagement region of the tissue penetrator. Asecond bight at the second end of the same suture is held to the side ofthe tissue penetrator and the end region of the suture distal from thesecond bight region is coupled to the tissue penetrator by a releasablehold 470 configured as a clasp in this example. The tissue penetratormay be coupled to a sled (e.g., needle sled) 475 that is also heldwithin the jaw housing. As described in detail below in some variationsa separate releasable hold is not required; for example the sled may beconfigured to include the releasable hold (see, e.g., FIG. 11A). Aneedle sled may act to couple the tissue penetrator to a push/pull rodin the durable component for actuating the needle. The lower jaw housingmay also include a cover (e.g., top cover) 407 over all or a portion ofthe jaw housing, such as the distal end region. Additional suturemanagement regions may also be included, such as a funnel 417 that canbe used to guide the suture within the housing, and help prevent it fromtangling within the housing or getting pinched between a wall of thehousing and the needle.

FIGS. 5A-5C show additional detail of a variation of an assembledcartridge such as the one shown in FIG. 4A. In FIG. 5A, a top view ofthe distal end region of the assembly shows a housing 509, top cover507, and tissue penetrator 503. A releasable hold 570 is coupled to thetissue penetrator, holding a distal end region of a suture 560. Thehousing includes a flanged region 544 to engage with a durable assemblyof a suture passer, and a ramped deflection region 533 to direct thetissue penetrator laterally from the cartridge.

FIG. 5B shows a side perspective view and FIG. 5C shows a side view. Ascan be seen in FIG. 5B, the cartridge, and particularly the lower jawregion 505 is thin and relatively flat. FIG. 6 is an enlarged andexploded view of the distal end of the cartridge, showing the housing509, a suture 560 (including a first bight region 561 and second bightregion 563), tissue penetrator 503 (including suture engagement region513), a releasable hold (clasp 570), top cover 507, and suturemanagement element (funnel 517).

Similarly, FIGS. 7A and 7B show a top view of the distal end region of acartridge. In FIG. 7A a top cover has been made removed to show how thebights and end regions of the suture engage with the tissue penetratorwithin the cartridge. As shown in FIG. 7A, the first bight 761 of sutureis held in the suture engagement region 713 of the tissue penetrator. Atissue penetrator generally retains a suture so that the suture can bepushed (or, in some variations pulled, or pushed and pulled) through thetissue by the tissue penetrator until it is held by a suture retainer onthe opposite jaw. For example, in FIG. 7A, the tissue penetratorincludes a notched region forming the suture engagement region 713; thenotch is oriented at an angle relative to the length of the tissuepenetrator, directed proximally, so that the suture is retained withinthe tissue penetrator as it is advanced distally. Other sutureengagement regions may be used, including distal-facing sutureengagement regions, or the like.

In FIG. 7A, a single suture forms the first and second bight regions;the portion of the suture between the first bight 761 and the secondbight 763 runs behind the tissue penetrator (not visible in FIG. 7A),between the tissue penetrator and the jaw housing 709. The second bightregion 763 on the opposite end of the suture is held in a suture holdingregion 722 that is off of the tissue penetrator, while the distal endregion of the suture just distal to the second bight region 763 issecured to the tissue penetrator by the releasable hold (not visible inFIG. 7A, but see, e.g., FIG. 5A). The suture holding region 722 in FIGS.7A and 7B is a notched region formed within the jaw housing laterallypositioned relative to the tissue penetrator, and on the same side ofthe tissue penetrator as the opening into the suture engagement region713 of the tissue penetrator 703. In operation, the suture holdingregion holds the second bight until the suture engagement region of thetissue penetrator is empty (e.g., of a bight of suture).

As used herein, a bight or bight region of suture refers to a length ofsuture. The length of suture forming the bight may be bent or looped;for example, the bight region may be bent so that the suture bends 180degrees, as illustrated in FIG. 7A and FIG. 7C, discussed below. In somevariations the bend forming the bight may prevent the suture fromsliding or pulling distally or proximally.

As mentioned above, any of the suture passer apparatuses describedherein may include a gate to prevent entanglement and/or entrapment of asuture. FIGS. 9A-9C illustrate the problem of entrapment or entanglementusing a suture passer as shown above, similar to the one shown in FIGS.3A-4C. When passing a suture using a preloaded suture passer as shown inFIGS. 3A-4C, the tissue penetrator may initially push a first(preloaded) bight of suture through a tissue held between the first andsecond jaws 903, as shown in FIG. 9A. Thereafter, the first bight isheld in the tissue and the suture passer may be repositioned in a secondlocation to pass the second bight of tissue and form the completed nextbight. In variations in which the distal end region of the lower jaw 909includes a channel (see, e.g., FIG. 5A, opening 577 into the distalchannel), once the length of suture has been passed and has left thelower jaw member into which it was preloaded, it is possible for thelength of suture to re-enter this channel in the lower jaw and getentangled in the tissue penetrator and/or the second bight of thesuture, such that once the tissue penetrator is again passed through thetissue, it will extend this entangled region as well as the second bightthrough the tissue, as shown in FIG. 9B. In FIG. 9B, the entangled firstregion 955 is held within the capture region of the upper jaw,potentially preventing the suture passer from correctly withdrawing fromthe tissue, damaging the tissue, and compromising the procedure. FIG. 9Cshows an actual figure from which this failure mode was identified in acadaver knee procedure.

One technique for addressing this failure mode is illustrated in FIGS.10 and 11A-11H. As shown in FIG. 10, in any of the variation of suturepassers shown herein, the distal end may include a deformable gate 1010that is configured to prevent a loop of suture from passing through themetal gate and into the channel 1013 into the lower jaw, which scontinuous with the path taken by the tissue penetrator within the lowerjaw. In FIG. 10, the gate member is a pin that is attached at one end,but otherwise is free to move into a distal open position, but isprevented from opening proximally and allowing suture to enter thechannel. In alterative variations, the gate pin shown in FIGS. 10 and11A-11H includes is flexible and closes as shown in FIG. 10, anddynamically illustrated in FIGS. 11A-11H, described in greater detailbelow.

For example, in FIG. 11A, the distal end region of a lower jaw membershows the gate pin 1010 in a ready position, closed, but with a bight ofthe first preloaded suture looped over the gate pin. The partiallytransparent view shown in FIG. 11B illustrates the preloaded firstlength of suture loaded into the cut-out region in the tissuepenetrator, and FIG. 11C illustrates how the tissue penetrator continuesto extend through the tissue and pull or push the first length of suturealong with it, and away from the gate pin. In FIG. 11D, the first bightbeen fully passed into the tissue and the needle (tissue penetrator)withdrawn. As shown in FIGS. 11E-11G, thereafter the region of thesuture 1105 may be pulled away from the suture passer (lower jaw) and,the gate pin 1103. This is illustrated in FIG. 11G, showing the gate pin1105 bending distally away to allow the suture length to be removed fromwithin the channel 1107, after opening the gate 1103. As shown in FIG.11H, once the suture length (connected to the first region of suturepassed through the tissue) has been pulled out of the channel 1107, thegate 1105 prevents any suture from re-entering the channel 1107, whereit may become entrapped by the tissue penetrator.

In FIG. 11A, one end of the suture is routed around the gate pin, whichcan swing out but not back in. As shown in FIG. 11B, the suture is stillloaded around the needle but the additional routing around the gate pinplaces the suture outside the jaw upon exit. After passing the suture asnormal (FIGS. 11C and 11D), the device is retracted, and the firstsuture end is routed outside the pin is still on the outside but thesecond suture end is inside the device, as shown in FIG. 11E. After theend of the suture has paid out from the cartridge (as shown in FIG.11F), the final bight of the suture gets caught on the gate pin, whichcan flex (FIG. 11G) and allow the release of the final bight, therebyfreeing the suture from the cartridge. Thereafter, the gate pin springsback towards its original position, as shown in FIG. 11H.

FIGS. 12A and 12B illustrate another variation of a suture passer and/orpreloaded cartridge for a suture passer that is configured to prevent alength of suture (e.g., already passed suture) back into the channel inthe jaw where it may be entrapped by the tissue penetrator. In thisexample, the terminal end of the first preloaded suture bight region1201 is wrapped around the lower jaw member as shown in FIGS. 12A and12B, preventing it from re-entering the opening at the distal end 1207.FIG. 12B shows the back of the lower jaw member, while FIG. 12A showsthe front. The jaw may include an outer channel (not shown) for holdingthe wrapped suture.

In operation, the preloaded suture passers described herein may be usedto suture any appropriate tissue, not limited to knee (e.g., meniscus,ACL, etc.), hip (e.g., hip labrum, etc.), shoulder (e.g., rotator cuff),etc. For example, FIGS. 8A-8L illustrate one method, including optionalsteps, of using a preloaded suture passer to repair tissue; in thisexample, the meniscus includes a tear 2609 which may becircumferentially stitched by placing a first end of the suture throughthe meniscus on one side of the tear, and placing the opposite end ofthe suture on the other side of the tear.

In FIGS. 8A and 8B, the suture passer is first assembled by coupling apreloaded cartridge 2603 with a durable assembly 2605 to form a suturepasser 2601. In FIG. 8C, the suture passer is positioned adjacent to thetarget (torn meniscus) tissue; in this example, the upper jaw of thesuture passer is pivotable/bendable relative to the elongate axis of thedevice, and the lower jaw is axially retracted (proximally) so that thetip of the suture passer has a very narrow profile and can fit into thenarrow confines of the anatomy. In FIG. 8D, the lower jaw is extendeddistally to surround the torn meniscus. In FIG. 8E the tissue penetrator2611 is extended from the lower jaw (from the cartridge) to the upperjaw while pushing a first bight region of suture. The tissue penetratoris then retracted, leaving the first bight region of suture at a firstend of the suture held in the suture retainer region 2618 of the upperjaw, as shown in FIG. 8F. The suture 1615 then extends from the upper(superior) side of the meniscus and the upper jaw to the lower(inferior) side of the meniscus and the lower jaw. Withdrawing thetissue penetrator into the lower jaw housing (shown in FIG. 8E) mayautomatically re-load the tissue penetrator with the second bight ofsuture near the distal end of the suture, as discussed above. Forexample, when the second bight of suture is held in a fixed position andthe distal end region of the suture next to the second bight is held ina releasable hold on the tissue penetrator, the tension pulling thesecond bight proximally may pull the second bight into the sutureengagement region (now empty) on the tissue penetrator. Thisautomatically re-loads the tissue penetrator with a second bight oftissue.

In FIG. 8G the suture passer is repositioned on the meniscus so that itcan suture on the more apical side of the tear 2609. Once positioned,the suture passer is again activated (e.g., by actuating the lowerjaw/needle extension control on the handle) to drive the tissuepenetrator from the lower jaw through the tissue to the upper jaw, wherethe second bight region also engages with a suture retainer 2618 in theupper jaw. The same or a different suture retainer may be used.Withdrawing the tissue penetrator again leaves the second length 2619 ofsuture behind in the meniscus, as shown in FIG. 8H. Thereafter, thelower jaw can be retracted, leaving the suture “slack” 2622 (the suturebody) on the inferior side of the meniscus, and allowing the loop to beclosed by withdrawing the suture passer (including the upper jaw) fromthe knee, as shown in FIG. 8J. A knot pusher (not shown) can then beused to tighten and tie a knot in the loop of suture, repairing thetear, as shown in FIG. 8K. The cartridge may then be removed from thedurable assembly, as shown in FIG. 8L, and another (new) cartridge maybe applied.

Asymmetric Needles

The needles shown in FIGS. 4A-7C above are typically symmetric at theirdistal tip. For example, compare needle of FIG. 13B (symmetric) with theneedle of FIG. 13A (not symmetric). Making the needle tip asymmetricsuch that the tip resides in the lower jaw channel may also help solvethe problem described above with recapture of the suture length by thetissue penetrator.

The tissue penetrators (needles) described herein typically have a sharpdistal tip that is adapted to penetrate tissue. The sharp distal tip maybe located anywhere along the width of the tissue penetrator. Forexample, the sharp distal tip may be centered relative to the width, asshown in FIG. 7A, or it may be laterally offset from the midline of thetissue penetrator (where the midline extends in a proximal to distaldirection).

In some variations, it may be desirable to have the sharp distal tipregion laterally offset from the midline of the width, as illustrated inFIG. 14A. In particular, in variations in which the jaw member in whichthe tissue penetrator is housed include a longitudinal suture loadingchannel. However, a needle having a centered sharp distal tip may snagor catch on the suture when loading the suture into the central channel.For this reason, a laterally offset sharp distal tip. An asymmetricneedle tip offers advantages for loading suture when there is a centralsuture loading channel in the lower jaw, because having the needle tipoff to one side of the loading groove may ensure that the sharp tip ofthe needle is not exposed to the suture, mitigating the chances that thesuture will snag on the needle tip, as shown in FIG. 14A. The centralsuture-loading channel 4907 in the jaw 4916 is continuous with a sutureholding region 4901 and the entire channel (and thus any suture heldwithin the channel) is protected from the sharp distal tip 4905, as thesharp distal tip 4905 of the tissue penetrator 4903 is laterallydisplaced and is held within the jaw 4916.

In general, tissue penetrators having less asymmetrically located sharpdistal tips (e.g., less laterally offset from the midline) may have lessof a tendency to deviate laterally when extending through the tissue,and may therefore have a higher reliability when contacting the sutureretention feature in the opposite jaw. However, to ensure that suturecan enter the loading area of the suture passer without snagging on theneedle tip, the shape of loading channel may be modified to cover theneedle tip. For example, FIG. 14B illustrates one variation of a jawhaving a central suture loading channel 4907 to load a suture into atissue penetrator. The jaw includes a ramped cover 4911 housing thecentrally (or slightly offset from the midline, e.g., less than 30%offset, less than 25% offset, less than 20% offset, less than 15%offset, etc. from the midline) located sharp distal tip 4905′ of thetissue penetrator 4903′. Thus, a suture may be protected from snaggingon the tissue penetrator tip when being loaded in the central channel4907.

Any of the tissue penetrators described herein may also be adapted toprevent snagging of tissue (e.g., capsule or meniscal tissue) whenextending through the tissue. Any of the suture passers described hereincould be used for repair of soft tissue in joints, to sew in allograftsor artificial soft tissue constructs such as an artificial meniscalscaffold or graft, and/or for meniscus repair.

In some variations the jaw member housing the tissue penetrator may alsoor alternatively be reconfigured to prevent or reduce the likelihood ofentrapment/recapture of the suture in the jaw (e.g., by the tissuepenetrator). For example, in some variations, the lower jaw may bereconfigured to have a closed distal end that the suture wraps around,similar to the pin, but without having to open. Instead, the distal endregion of the jaw may include a laterally-offset opening into the distalchannel. As shown in FIG. 15, this may allow the suture to escape thelower jaw through a side channel 1501, while preventing a suture fromeasily entering the distal end of the jaw member.

Alternatively, in some variations, the opening at the distal end(distally—facing opening) into the channel within the jaw member housingthe tissue penetrator is still present, but is adapted to reduce thelikelihood of a suture re-entering the channel. This may be achieved byhaving a very narrow channel (e.g., having a diameter approximately thesame as or just slightly larger than the diameter of the suture); theouter edge of the channel may transition abruptly from a smooth orrounded distal-facing surface, which does not guide a suture into thechannel. This very narrow channel at the tip of the lower jaw maytherefore allow the suture to escape when the suture is in tension 1601,but would be narrow enough to make it difficult for the suture to enterthe lower jaw channel when the lower jaw is pushed against the suture.

Although many of the variations of suture passer devices describedherein are configured so that the tissue penetrator extends distallyfrom an opening in a jaw, any of the suture passers described herein maybe configured so that the tissue penetrator extends proximally afterextending between the upper and lower jaws. Thus, the deflectionfeatures on the upper jaw could be set to facilitate the needle headingin the proximal direction. For example, in some variations the tissuepenetrator extends proximally within (or out of) the upper jaw memberafter extending across the opening between the jaws.

Centering Second Suture Bight

Any of the apparatuses described herein may include one or more featuressuch as a centering channel that pulls a second bight of suture into theneedle's hook as the needle is retracted (e.g., when reloading thesuture into the needle), which may help in positioning the second bightof suture within the hook, to ensure that the suture is loaded andpassed successfully.

For example, FIGS. 13A-13C illustrate examples of needles having hooksthat may be preloaded with a first length of suture and then reloadedwith another length of suture into a hook of the needle.

In some variations, the needle is coupled to a sled or or sleeve. Thesled may be attached to the needle, and may travel with the needle. Asdescribed in U.S. application Ser. No. 14/572,485, filed Dec. 16, 2014(US-2015-0196294), now U.S. Pat. No. 9,494,162, herein incorporated byreference in its entirety, a needle sled may be used to releasably holdand apply tension to a second suture end so that it may be pulled intothe hook region of the needle when the needle is withdrawn back into thesuture passer after passing the first length (end) of suture. Forexample, once the needle has been extended, and as it is retracted, theneedle sled may apply tension to the second suture end held by the sledor a releasable attachment on the sled. In some variations, as describedherein, the lower jaw in which the needle is slide and retained, mayinclude a suture guiding feature (“suture guide”) through which thesecond suture end may be threaded. The suture guide feature may beshaped and positioned relative to the needle hook such that when thesuture is tensioned, the suture is pulled centrally and loaded into thehook of the needle. The needle can then be re-advanced to pass thesecond suture end.

In another embodiment, the second suture end is tensioned by the needlerather than by the needle sled.

FIGS. 17A-17E illustrate passing both ends of a suture. For example, inFIG. 17A, a first/lower jaw 1701 includes a needle 1703 that is coupledto a sled 1705, and a first suture end 1709 is preloaded into the needlehook, while the second bight (a loop at the second end of the suture) isheld within the first jaw 1707, e.g., in a suture holding region withinthe first/lower jaw, and the second end region 1711 is held on the sled1705. The first end of the suture is passed through the tissue byextending the needle 1705 (and sled coupled thereto) distally, as shownin FIG. 17B. When the needle and sled are retracted proximally, as shownin FIG. 17C and 17D, the second end of the suture is tensioned as thesled moves proximally, so that the bight of suture near the second endthat is held in the suture holding region within the first/lower jaw canthen be pulled into the hook region of the needle, as shown in FIG. 17D.Thereafter, the needle with the loaded second bight region can then bepassed through the tissue to pass the second end, as shown in FIG. 17E.

As just discussed above, the step of moving the second bight region intothe hook of the needle is important, because if it is not properlyperformed, the suture (second bight) may not be loaded properly and mayfall out of the needle, or may only be partially loaded. Describedherein are devices and methods of using them for directly the tension inthe second bight/second end of the suture so that it may more accuratelybe loaded into the hook of the needle. For example, in some variations,a suture guide (e.g., centering channel) may be included to assist inloading the second suture (second bight) into the needle hook. FIGS. 18Aand 18B illustrate one example of a suture apparatus as described hereinin which a suture guide is included to guide the tensioned second bightregion of the suture that is preloaded within the first/lower jaw sothat the second bight is pulled reliably and completely into the hook ofthe needle. The suture guide may be part of the suture holding regionwithin the jaw housing, or it may be separately attached to thefirst/lower jaw.

For example, FIGS. 18A and 18B, a suture guide feature 1805 is includedas part of the first/lower jaw 1803, and the needle slides relative tothe suture guide feature. In this example, the suture guide featureloads the second suture bight region into the needle hook after thefirst bight has been passed, and the needle retracted 1807 proximally.The suture guide feature (or guide feature) 1805 include an eyeletforming a channel that provides a centrally directed force vector tomove the suture centrally (toward the midline of the first/lower jaw)and therefore into the hook region of the needle, as shown in FIG. 18B.FIGS. 19A-19D illustrate other variations of suture guide features asdescribed herein. In FIGS. 19A-19D the guide feature includes a channelor opening near the longitudinal midline of the first/lower jaw overwhich the suture may wrap. When the needle and sled are moved proximallyafter passing the first suture bight preloaded into the device, thesecond bight is held within the suture holding region within of the jawhousing laterally offset from the longitudinal midline of thefirst/lower jaw; the guide feature is positioned opposite and slightlyproximally to the suture holding region within the jaw housing, andincludes a channel for the second bight region of the suture thatdirects the second bight region centrally (toward the midline of thefirst/lower jaw 1901) when a cut-out portion of the needle (such as thehook region) exposes the channel of the guide feature 1905 allowing thesecond bight to transition from the suture holding region (e.g., asuture holding region within the jaw housing) into the midline region ofthe jaw along the channel of the guide feature.

As mentioned above, if a suture guide feature is not used, the needlesled may apply tension to the suture without a midline-directed vector(e.g., a vector having a centrally directed component). Without somecentrally directed component of tension, it is possible for the needlehook to miss the second leg of the suture, leaving the second leg of thesuture to get pulled into the gap between the needle and the lower jaw,as illustrated in FIG. 20A, showing a suture 2001 falling into the gapbetween the needle 2005 and the suture holding region within the jawhousing. Another possible consequence of pulling on the second suturewithout a vector that has some centrally directed component is that thetip of the needle hook may grab a partial set of suture strands, but notthe entire diameter of the suture, as illustrated in FIG. 20B, showing aneedle 2001 hook, in which the needle has been advanced past the pointwhere it is supposed to pick up the second bight, separating the suture2005, as shown.

The suture guide features described herein may also be referred ascentering features or as centering channels, and may be coupled orintegral to the jaw (e.g., the first/lower jaw member). In particular,these centering features/centering channels may be formed through thejaw housing within which the tissue penetrator slides. A centeringchannel may include a channel is that is oriented centrally andconfigured to provide a force vector on the second bight of suture thatis preloaded into a second bight region of the jaw to move the secondbight towards the midline of the lower jaw when the needle is retracted.In general, the centering channel may be opposite from, radially inwardto (e.g., towards the midline of the long axis), and slightly proximalto, the suture holding region within the jaw housing and located moreclosely toward the midline.

In general, the centering channel may include at least one loop throughwhich a leg of the second bight is threaded. In FIGS. 18A-19D, thecentering channel includes a pair of openings through an “upper” surface(or outer surface, such as the surface facing the opposite jaw) of thejaw housing that are connected by a recessed region (recessed channel),recessed relative to the surface of the jaw housing, within which thesuture leg passes. The centering channel may be positioned slightlyproximally and away from the suture holding region in the jaw housing.For example, in FIG. 19D, the suture holding region of the jaw housing1950 is shown on the top of the figure in the jaw housing, while thecentering channel is formed of a pair of openings through the uppersurface of the jaw housing 1960 that are connected by a recessed channel1905 between the two. The recessed channel is recessed down into theupper surface of the jaw housing 1960, and reduced the contact andfriction between the suture and any tissue held in the jaws. In generalthis upper surface of the jaw housing is attached or integrally formedwith the rest of the jaw housing forming the jaw (in this example, alower jaw) and the tissue penetrator is slidelaby held within the jawhousing. FIGS. 19B and 19D show examples where the centering channel1905 is positioned on an opposite side of the upper jaw housing awayfrom the suture holding region of the jaw housing. Having a pair ofopenings through the upper surface of the jaw housing allows the sutureto thread out and then back in while providing a centering force vector,so that the majority of the suture is held within the jaw housing,rather than running on top of the jaw housing, although a single hole ormore than two openings (holes) may be used.

Although the description above is broken into parts and includesspecific examples of variations of suture passers, any of the featuresor elements described in any particular example or section may beincorporated into any of the other embodiments. Although the foregoinginvention has been described in some detail by way of illustration andexample for purposes of clarity of understanding, it is readily apparentto those of ordinary skill in the art in light of the teachings of thisinvention that certain changes and modifications may be made theretowithout departing from the spirit or scope of the appended claims.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A suture passer apparatus with a preloadedsuture, the apparatus comprising: an elongate body extending distallyand proximally; a first jaw coupled to a distal end of the elongatebody; a second jaw having a channel extending proximally from a distalend region of the second jaw; a tissue penetrator configured to slidedistally and proximally within the second jaw; a suture within thesecond jaw, the suture comprising a first bight region loaded in asuture engagement region at a distal end region of the tissuepenetrator, and a second bight region loaded in a suture holding regionwithin the second jaw; and a gate at the distal end region of the jawhousing, wherein the gate is configured to open distally to allow therelease of the suture from the channel, and to close to prevent aportion of the suture from re-entering the channel.
 2. The apparatus ofclaim 1, wherein the gate comprises a deflectable pin.
 3. The apparatusof claim 1, wherein the gate comprises a turnstile mechanism.
 4. Theapparatus of claim 1, wherein the second jaw is configured to enclosethe tissue penetrator until the tissue penetrator is extended from thejaw housing.
 5. The apparatus of claim 1, wherein the first jaw isconfigured to pivot relative to the elongate body and wherein the secondjaw is configured to slide axially relative to the elongate body.
 6. Theapparatus of claim 1, wherein the second jaw is removable.
 7. A suturepasser apparatus with a preloaded suture, the apparatus comprising: anelongate body extending distally and proximally; a first jaw coupled toa distal end of the elongate body; a removable second jaw having achannel extending proximally from a distal end region of the second jaw;a tissue penetrator configured to slide distally and proximally withinthe second jaw; a first length of suture within the second jaw, thefirst length of suture comprising a first bight region loaded in asuture engagement region at a distal end region of the tissuepenetrator; a second length of suture within the second jaw, the secondlength of suture comprising a second bight region loaded in a sutureholding region within the second jaw; and a gate at the distal endregion of the jaw housing, wherein the gate is configured to opendistally to allow the release of the first or second length of suturefrom the channel, and to close to prevent a portion of the first orsecond length of suture from re-entering the channel.
 8. The apparatusof claim 7, wherein the gate comprises a deflectable pin.
 9. Theapparatus of claim 7, wherein the gate comprises a turnstile mechanism.10. The apparatus of claim 7, wherein the second jaw is configured toenclose the tissue penetrator until the tissue penetrator is extendedfrom the jaw housing.
 11. The apparatus of claim 7, wherein the firstjaw is configured to pivot relative to the elongate body and wherein thesecond jaw is configured to slide axially relative to the elongate body.12. A replaceable jaw cartridge that is preloaded with suture, the jawcartridge comprising: a jaw housing configured to releasably engage asuture passer device, the jaw housing enclosing a channel extendingproximally from a distal end of the jaw housing; a tissue penetratorconfigured to slide distally and proximally within the jaw housing; afirst length of suture within the jaw housing, the first length ofsuture comprising a first bight region loaded in a suture engagementregion at a distal end region of the tissue penetrator; a second lengthof suture within the jaw housing, the second length of suture comprisinga second bight region loaded in a suture holding region within the jawhousing; and a gate at the distal end region of the jaw housing, whereinthe gate is configured to open distally to allow the release of thefirst or second length of suture from the channel, and to close toprevent a portion of the first or second length of suture fromre-entering the channel.
 13. The jaw cartridge of claim 12, wherein thegate comprises a deflectable pin.
 14. The jaw cartridge of claim 12,wherein the gate comprises a turnstile mechanism.
 15. The jaw cartridgeof claim 12, wherein the jaw housing is configured to completely enclosethe first length of suture, the second length of suture and tissuepenetrator until the tissue penetrator is extended from the jaw housing.16. The jaw cartridge of claim 12, wherein the jaw housing comprises akeyed connector configured for coupling with an elongate member of thesuture passer device.
 17. The jaw cartridge of claim 12, wherein thedistal tip of the tissue penetrator is laterally offset with respect toa centerline along a length of the channel.
 18. The jaw cartridge ofclaim 12, wherein the channel comprises a ramp adapted to guide thetissue penetrator away laterally out of the jaw housing at the distalend region.
 19. The jaw cartridge of claim 12, wherein the sutureholding region is positioned opposite from the suture engagement regionof the tissue penetrator when the tissue penetrator is withdrawnproximally within the jaw housing.